ANTICANCER RESEARCH 26: (2006)

Size: px
Start display at page:

Download "ANTICANCER RESEARCH 26: (2006)"

Transcription

1 Gemcitabine plus Mitoxantrone and Prednisone in the Palliative Treatment of Hormone-resistant Prostate Cancer (HRPC): A Phase II Study (GOAM Study) ANTONIA CRICCA 1, ANTONELLA MARINO 1, DANILA VALENTI 2, BARBARA MELOTTI 1, ELENA AMADUCCI 3, CRISTINA GUARDIGLI 4, MANUELA LENZI 5, GIUSEPPE MARTORANA 6, PIERFRANCESCO BULI 7 and ANDREA ANGELO MARTONI 1 on behalf of Gruppo Oncologico Aree Metropolitane (GOAM) 1 Medical Oncology Unit and 6 Urology Unit, S.Orsola-Malpighi University Hospital, Bologna; 2 Hospice "MT Seragnoli", Bentivoglio, Bologna; 3 Oncology Service, Hospital of Budrio, Bologna; 4 Medical Oncology Unit, Hospital of Imola, Bologna; 5 Oncology Service Vergato, Bologna Sud; 7 Urology Unit, Hospital of S.Giovanni in Persiceto, Bologna, Italy; Abstract. Background: The present exploratory phase II study was performed to evaluate the activity and tolerability of adding a second agent (gemcitabine) to the well-tolerated mitoxantrone/prednisone regimen in patients with locally advanced or metastatic prostate cancer no longer responsive to hormonal treatment. Patients and Methods: Forty-three patients with hormone-refractory prostate cancer (HRPC) were included in the study from May 2000 to April Their median age was 71 years (range, 56-81) and their median Karnofsky performance status (KPS) was 90 (range, ). The treatment schedule consisted of intravenous (i.v.) mitoxantrone (8 mg/m 2 on day 1), i.v. gemcitabine 800 mg/m 2 on days 1 and 8, recycled every 21 days and oral prednisone administered at a dose of 10 mg per day. Hormonal treatment with LHRH was continued in all patients. Up to six cycles of treatment were planned in the absence of progressive disease. Results: Sixteen patients had measurable disease (six patients only measurable disease, ten patients bone disease plus measurable disease) and 27 patients had only bone disease. Concerning the PSA levels, a partial response (PR) was observed in 15 patients (38%), stable disease (SD) in 16 patients (41%) and progressive disease (PD) in eight patients Correspondence to: Andrea Angelo Martoni, Unità di Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, via Albertoni 15, Bologna, Italia. Tel: , Fax: , martoni@aosp.bo.it Key Words: Prostate cancer, hormone-resistant prostate cancer, gemcitabine, mitoxantrone, prednisone. (21%). The objective response was evaluable in 16 patients; one patient was not evaluable because he had received only one cycle. Ten patients (63%) had SD and five patients (31%) PD. In the ten evaluable patients with objective SD, depending upon the PSA response, three PR, six SD and one PD were observed. Among the five patients who progressed, three PD and two SD were observed as a PSA response. Pain remission was recorded in 15/41 patients (36%) and the KPS remained stable in most patients. The median overall survival was 15 months (range, 1-41) (95% CI: months). The 1-year survival rate was 61%. Hematological toxicity was mild: G 3-4 neutropenia was observed in five (12%) patients. There were no neutropenic fevers. No significant non-hematological toxicity was observed. Conclusion: The mitoxantrone, gemcitabine and prednisone combination, in accordance with the present regimen, was feasible, had a palliative effect, good tolerance and antitumor activity. Nonetheless, our results do not seem to be superior to those previously described for mitoxantrone plus prednisone. Prostate cancer is a significant health problem throughout the world and is the most common male malignancy and the most frequent cause of male cancer mortality, second to lung cancer (1). The American Cancer Society estimates that, during 2005, approximately 232,090 new cases of prostate cancer will be diagnosed in the United States and 30,350 men will die of metastatic disease (2). In Europe, the incidence rate is 55 cases per 100,000 and the mortality rate 22.6 per 100,000. About 10-20% of men with prostate cancer present metastatic disease and, in many others, metastases develop despite treatment with surgery /2006 $

2 or radiotherapy. Androgen deprivation is the standard therapy for newly-diagnosed metastatic cancer and produced symptomatic improvements in 60-70% of patients, but resulted in only a slight prolongation of both progression-free survival (PFS) and overall survival (OS) (3). Despite initially effective hormonal ablation therapy for patients with metastatic prostate carcinoma, the vast majority of these patients progress to a hormone-refractory state. Hormone-refractory adenocarcinoma of the prostate continues to be a major cause of morbidity and mortality among American men. Low response rates and significant toxicity have led to understandable scepticism concerning the use of chemotherapy in the treatment of this disease (4, 5). This scepticism has been challenged by new developments resulting from trials guided by the description of the action mechanisms of several new antineoplastic agents, the definition of appropriate study end-points and a better understanding of the biology of prostate cancer. For the clinician, the number of potential therapeutic options narrows at a certain point in patients with metastatic hormone-refractory prostate cancer. For those patients, irrespective of the interventions, the median survival is only 8-12 months (6). When patients with symptomatic hormone-resistant prostate cancer (HRPC) are treated with chemotherapy, the treatment goals are an improvement in survival duration and quality. Tumor response is not an end-point of patient benefit and its determination has been hampered by the relative infrequency of measurable disease to which standard response assessments can be applied (7). The difficulties in determining the activity of new agents in HRPC are mainly related to the fact that only about 20% of patients have a bi-dimensionally measurable disease (8). Metastases, typically occurring in the bone, are hard to evaluate by bone scan, so the standardised response criteria commonly used in other solid tumors are inadequate. Chemotherapeutic agents have shown, given these limits, a response rate ranging from 15-30%. Clearly, survival remains the most important goal, but none of the cytotoxic agents used to date has been shown to have a significant impact on survival (9, 10). Therefore, surrogate end-points were developed in the 1990s, such as changes in the PSA serum levels and palliation (11, 12). Clinical response has been increasingly accepted as an alternative means for assessing activity in HRPC. Mitoxantrone has been used as a single agent in several phase II studies and has shown minimal activity in terms of response with a significant improvement in the symptoms of chemotherapy-naïve patients. The combination of mitoxantrone with prednisone demonstrated a significant palliative benefit in a multicenter phase II study with improvement in social and emotional functioning, as well as improved pain scores (13). Two phase III studies were started in the early 1990s addressing the question of whether the addition of mitoxantrone to corticosteroids, at that time considered the standard treatment, was better than corticosteroids alone. The first study compared low-dose prednisone alone (P) with mitoxantrone in combination with low-dose prednisone (MP). The primary end-point of the trial was a palliative response, defined as changes in the patient symptom scores and analgesic requirements. The palliative response rate was 38% for the MP arm and 21% for the P arm, with a longer duration of response for patients randomly assigned to receive chemotherapy. The patients in the combination arm achieved a better and longer duration of palliation. The PSA response (decrease in serum PSA 50%) was 33% for the MP arm and 22% for the P arm (14). The Cancer and Leukemia Group B conducted a similar randomised trial (CALGB 9182), comparing mitoxantrone plus hydro-cortisone with hydrocortisone alone. Although no difference was seen in the primary end-point (survival) (12.6 months vs months), a modest delay in time-to-progression and a better pain control were observed in patients treated with chemotherapy. Thirty-eight per cent of the 112 patients who received mitoxantrone plus hydro-cortisone achieved a maximum serum PSA decrease of 50% compared with 22% of 116 patients who received hydrocortisone alone (p=0.008) (15). Consistent benefits of mitoxantrone plus a corticosteroid were observed in other randomised trials, but none found that this approach improved survival. On the grounds of the two studies above, the United States Food and Drug Administration approved mitoxantrone for use in HRPC (16). These trials established mitoxantrone plus a corticosteroid as the treatment of reference for HRPC. Gemcitabine (G) demonstrated activity in experimental prostatic tumors. Both alone and in combination with other chemotherapeutic agents, gemcitabine showed a powerful capacity to inhibit the in vitro and in vivo growth of several prostate cancer cell lines (17). Furthermore, gemcitabine has shown some positive results in such patients as well: in a phase II trial, 43 patients with HRPC were treated with gemcitabine and three (RR: 7%) showed a PSA response: one CR and three PR with time-to-treatment failure of 8.7, 6.6 and 9.3 months. Seven patients (16%) had stable disease for a median duration of 7.1 months (range months). There was one case with objective regression of lymph node metastases. Despite its limited activity in terms of PSA response, gemcitabine showed a significant beneficial impact on pain (18). On the basis of these data, the present exploratory phase II trial was conducted to evaluate the feasibility of the mitoxantrone, gemcitabine and prednisone combination in patients with locally-advanced or metastatic prostate cancer no longer responsive to hormonal treatment. 2302

3 Cricca et al: Palliative Treatment of Hormone-resistant Prostate Cancer Patients and Methods Patients were eligible for the study if they had a histological diagnosis of adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease and a progressive disease after standard hormonal therapy. All the patients previously treated with an anti-androgen agent were required to undergo anti-androgen withdrawal. The patients were required to be off anti-androgens for at least 4 weeks with further evidence of disease progression after stopping the anti-androgen. The patients were also required to have a performance status of 70 on the Karnofsky scale, with a life expectancy of at least 12 weeks, no prior treatment with cytotoxic agents and adequate bone marrow (absolute neutrophil count 1,500/mm 3, hemoglobin level 10.0 g/dl and platelet count 100,000/mm 3 ), renal (creatinine 1.5 mg/dl) and hepatic function (bilirubin 1.6 mg/dl, serum alanine aminotransferase and aspartate aminotransferase 3 times the upper limit of the normal range). The patients were required to have measurable soft tissue disease, or assessable disease manifested as bone disease with a rising PSA level, or locally-advanced disease with a rising PSA level. Patients with PSA increase as a the sole manifestation of recurrent disease were excluded. Patients with any history of another cancer within the previous 5 years (except basal or squamous cell skin cancer) were excluded from the study. Patients with any history of recent myocardial infarction or ongoing ischemia requiring anti-anginal agents, arrhythmia requiring anti-arrythmics, or a history of ischemic disease with documented compromise of the left ventricular function were excluded from the study. Similarly, patients were also excluded from the study if they had uncontrolled hypertension, known brain metastases, or spinal cord compression. All the patients gave their written informed consent. Assessment. Pre-treatment evaluations consisted of a medical history and physical examination with assessment of performance status and laboratory studies, including complete blood count, serum chemistry profile, PSA level, radionuclide bone scan, ultrasound of the abdomen and pelvis, chest X-ray, electrocardiography and bone scan. Complete blood counts, including differential and platelet counts, were monitored weekly and chemistry profiles and PSA assessments were repeated every 3 weeks. Electrocardiography, cardiac examination and a reassessment of the metastatic sites, if present at baseline, were repeated every 9 weeks (three treatment cycles). Electrocardiography, cardiac examination, radionuclide bone scan, ultrasound of the abdomen and pelvis, chest X-ray and bone scan were repeated after six cycles of treatment. The evaluation of subjective symptoms (pain, asthenia, anorexia, dyspnea) was performed at baseline and just before starting each treatment cycle. Dose adjustments. The gemcitabine dose was omitted for a granulocyte count <1,500/Ìl and platelet count <100,000/Ìl on day 8. The administration of therapy on day 21 was delayed by a week and re-evaluated for a granulocyte count <1,500/Ìl and platelet count <100,000/Ìl. The gemcitabine and mitoxantrone doses were reduced by 25% for a grade 4 granulocyte count lasting more than 3 days, febrile neutropenia and grade 4 thrombocytopenia. The gemcitabine and mitoxantrone doses were reduced by 25% for a creatinine level of mg/dl. The gemcitabine and mitoxantrone doses were reduced by 50% for a creatinine level of mg/dl. The treatment was delayed by a week and re-evaluated after opportune hydration for a creatinine level >2.0 mg/dl. Treatment. The treatment schedule was as follows: M 8 mg/m 2 i.v. 30-min infusion on day 1, G 800 mg/m 2 i.v. 30-min infusion on days 1 and 8, recycled every 21 days; P was administered at the dose of 10 mg orally per day. Hormonal treatment with the LHRH analog was continued in all patients. Up to six cycles of treatment were planned in the absence of progressive disease. Response criteria and toxicity. The therapeutic effect was assessed using the standard WHO criteria for measurable disease (objective response), if present, or change in serum PSA level (PSA response) and pain evaluation. Toxicity was evaluated by means of the WHO criteria (19). Objective responses were assessed using the standard WHO criteria for patients with at least one bi-dimensionally measurable lesion, if present. A complete response (CR) was defined as the total disappearance of all clinically detectable disease measured by physical examination and/or radiographic studies for a period of at least 4 weeks. A partial response (PR) was defined as a 50% decrease in the sum of the products of the two longest perpendicular diameters of all measurable lesions for a period of at least 4 weeks, without an increase >25% in the size of any area known to contain malignant disease and without the appearance of any new areas of malignancy. Stable disease (SD) was defined as a regression not satisfying the above criteria for an objective response. Progressive disease (PD) was defined as an increase of at least 25% in the size of measurable lesions. The PSA response was evaluated in patients with measurable or non-measurable (i.e., bone metastases) disease and elevations in serum PSA. CR required the disappearance of all measurable and non-measurable but assessable lesions, with a decrease in serum PSA to less than 1.0 ng/ml for a duration of at least 4 weeks. PR was defined as a 50% decrease in any measurable lesions and/or at least 50% decrease in serum PSA for two consecutive measurements taken more than 2 weeks apart without progression of the non-measurable disease. PD was defined as the appearance of new lesions or an increase in PSA of 50% over the baseline or nadir value. SD was defined by a decrease in PSA level <50% without progression of measurable or non-measurable lesions. Survival was measured from the start of therapy to death, otherwise the patient was censored at the date of last follow-up. Pain was evaluated according to a threegrade coding system based on the consumption of analgesics (20). Statistical considerations. The study was designed to explore the efficacy of the combination of mitoxantrone, gemcitabine and prednisone in patients with locally-advanced or metastatic prostate cancer no longer responsive to hormonal treatment. The primary end-points of the study were to evaluate the PSA response to chemotherapy and pain remission. The secondary end-point was overall survival. A PSA response 40% in a series of about 40 consecutive patients was considered an interesting result that could justify the enlargement of the study. The response rates were assessed using PSA criteria for all patients and classic criteria for those with measurable disease. Patients not assessable for response were included in the denominator unless otherwise stated, providing a conservative estimate. Estimates of overall survival were obtained using the Kaplan-Meier method (21). Results Forty-three patients were enrolled in the study from May 2000 to April The patient characteristics are listed in Table I. The median age was 71 years (range, 56-81) and the 2303

4 Table I. Patient characteristics (n=43). Median age (years) (range) Median KPS (range) Metastasis sites No. % Only bone Only visceral sites 2 4 Only lymph nodes 3 7 Bone + lymph nodes 5 12 Bone + visceral sites 5 12 Lymph nodes + visceral sites 1 2 KPS: Karnofsky performance status. median Karnofsky performance status (KPS) was 90 (range, ). Sixteen patients had measurable disease (six patients only measurable disease, ten patients bone disease plus measurable disease) and 27 patients had only bone disease. A total of 248 treatment cycles were delivered to the 43 patients. The median number of cycles was six (range, 1-13). The data regarding the PSA treatment responses are listed in Table II. The PSA plasma levels during the treatment were evaluable in 39 patients, but not evaluable in four patients who only received one cycle. With regard to the PSA levels, a PR was observed in 15 patients (38%), SD in 16 patients (41%) and PD in eight patients (21%). The objective response was evaluable in 16 patients who had measurable disease; one patient was not evaluable because he had only received one cycle. Ten patients (63%) had SD and five patients (31%) PD (Table III). In the ten evaluable patients with objective SD, according to the PSA response, three PR, six SD and one PD were observed. Among the five patients who progressed, three PD and two SD were observed as a PSA response. Pain remission was registered in 15/41 evaluable patients (36%) and the KPS remained stable in most patients. The median overall survival was 15 months (range, 1-41) (95% CI: months) (Figure 1). The 1-year survival rate was 61%. All the patients were evaluable for toxicity. The hematological toxicity was mild: G 3-4 neutropenia was observed in five (12%) patients. There were no neutropenic fevers (Table IV), nor was significant non-hematological toxicity observed. Discussion Several clinical trials have evaluated the role of both singleagent and combination chemotherapy in the treatment of HRPC. Recent clinical trials have shown encouraging results in disease control and in the improvement of the quality of life. The combination of mitoxantrone and low-dose corticosteroids has been shown to improve the quality of Table II. PSA response. Serum PSA response No. % Evaluable patients Reduction 50% (PR) Reduction 0-50% (SD) Increase (PD) 8 21 PR: partial response; SD: stable disease; PD: progressive disease. Table III. Objective response (n=16). Objective response No. % Evaluable patients (measurable disease) PR 0 - NC PD 5 31 NE 1 6 PR: partial response; NC: no change; PD: progressive disease; NE: not evaluable. life in phase III trials without, unfortunately, prolonging disease-free survival or overall survival when compared with steroids alone. In these trials, the PSA response was 33-38% (14, 15). Many chemotherapeutic combinations have been reported in published studies with promising results. Among the cytotoxic combinations, including mitoxantrone, the combination of estramustine and mitoxantrone was investigated by the Hellenic Cooperative Oncology Group in 29 patients with HRPC in a phase II feasibility study. Twenty-seven per cent of patients with measurable softtissue disease showed an objective response, which included one CR and six PR. Thirteen patients (50%) had a 50% reduction in serum PSA level. The median duration of response was 9.2 months and the median survival for all patients was 15 months (22). In a subsequent phase II feasibility study, the same Hellenic Group investigated the combination of estramustine, vinorelbine and mitoxantrone in 52 patients with HRPC. Thirty-one per cent of patients with measurable soft-tissue disease demonstrated an objective response, which included six CR and ten PR in all involved organs (bone responses not included). Twenty-nine patients (56%) had a 50% reduction in serum PSA level. The median duration of response was 6.9 months and the median survival for all patients was 14.5 months (23). 2304

5 Cricca et al: Palliative Treatment of Hormone-resistant Prostate Cancer Table IV. Hematological toxicity (n=43). Toxicity (grade) I II III IV no. (%) no. (%) no. (%) no. (%) Anemia 4 (9) 3 (7) - - Leucopenia 14 (32) 6 (14) 3 (7) - Neutropenia - 2 (5) 3 (7) 2 (5) Thrombocytopenia 4 (9) Figure 1. Overall survival. The MVD regimen (mitoxantrone, vinorelbine, prednisone) in a phase II study in 28 patients produced a significant PSA level decline in eleven patients (46%) for a median duration of 11.4 months. Eight patients (33%) achieved a PR in terms of pain, while seven (29%) showed symptom stabilisation. The median duration of the response was 9.5 months (24). To date, no studies have reported the combination of mitoxantrone and gemcitabine. The present exploratory phase II study was designed to evaluate the activity and tolerability of the addition of a second agent (gemcitabine) to the well-tolerated regimen mitoxantrone/prednisone. Our combination produced a 50% reduction in serum PSA level in 38% of patients and pain remission in 36% of patients. We observed no objective response in patients with measurable disease: ten patients (63%) had SD and five patients (31%) PD. The median overall survival was 15 months (range, 1-38+) (95% CI: 11-19) and the 1-year survival rate was 61%. The hematological toxicity was mild: G 3-4 neutropenia was observed in five patients (12%). The mitoxantrone, gemcitabine and prednisone combination, in accordance with the present regimen, was feasible, had a palliative effect, good tolerance and antitumor activity and allowed us to obtain a PSA level reduction in patients with hormone-resistant prostate cancer. The PSA response observed and pain response were similar to those observed in two clinical trials with mitoxantrone and prednisone (14, 15). The results obtained did not seem to indicate that gemcitabine adds any beneficial effect to those described for the mitoxantrone and prednisone combination. Recently, a phase III trial (1006 patients) demonstrated that docetaxel every 3 weeks plus prednisone was superior in terms of survival (18.9 vs. 16.4), objective response (45 vs. 32%) and pain response rate (35 vs. 22%), as compared to mitoxantrone and prednisone (25). Another study (SWOG trial) (770 patients) demonstrated that docetaxel plus extramustine was superior when compared to mitoxantrone and prednisone: PSA declined in at least 50% in 50 vs. 27% (p<0.001); pain relief was similar in both groups (26). Given these results obtained with docetaxel and the similarity of the results observed in the present phase II pilot trial to those afforded by the mitoxantrone and prednisone regimen, the combination of mitoxantrone, gemcitabine and prednisone would not appear to warrant further studies. References 1 Parker SL, Tong T, Bolden S et al: Cancer Statistics. CA Cancer J Clin 47: 5-27, Jemal A, Murray T, Samuels A et al: Cancer statistics, CA Cancer J Clin 55: 10-30, Goktas S and Crawford ED: Optimal hormonal therapy for advanced prostatic carcinoma. Semin Oncol 26: , Tannock IF: Is there evidence that chemotherapy is of benefit to patients with carcinoma of the prostate? J Clin Oncol 3: , Eisenberger MA, Kennedy P and Abrams J: How effective is cytotoxic chemotherapy for disseminated prostatic carcinoma? Oncology 1(4): 59-71, Mahler C and Denis CJ: Hormone-refractory disease. Semin Surg Oncol 11: 77-83, Figg WD, Ammermann K, Patronas N et al: Lack of between PSA and the presence of invisible soft tissue metastasis in hormone-refractory prostate cancer. Cancer Invest 14: , Culine S and Droz JP: Chemotherapy in advanced androgenindependent prostate cancer A decade of progress? Ann Oncol 11: , Eisenberger MA: Chemotherapy for prostate carcinoma. NCI Monogr 7: ,

6 10 Yagoda A and Petrylak D: Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer 71: , Dawson NA: Response criteria in prostatic carcinoma. Semin Oncol 26: , Bubley GJ et al: Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 17: , Moore MJ, Osoba D, Murphy K et al: Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer. J Clin Oncol 12: , Tannock IF, Osoba D, Stockler MR et al: Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end-points. J Clin Oncol 14: , Kantoff PW, Halabi S, Conaway M et al: Hydrocortisone with or without mitoxantrone in men with refractory prostate cancer: results of the Cancer and Leukemia Group B 9182 Study. J Clin Oncol 17: , Small EJ, Reese DM, Vogelzang NJ et al: Hormone-refractory prostate cancer: an evolving standard of care. Semin Oncol 26(suppl): 61-67, Muenchen HJ, Quigley MM, Pilat MJ et al: The study of gemcitabine in combination with other chemotherapeutic agents as an effective treatment for prostate cancer. Anticancer Res 20(2A): , Morant R, Bernhard J, Maibach R et al: Response and palliation in a phase II trial of gemcitabine in hormonerefractory metastatic prostatic carcinoma. Ann Oncol 11: , Miller AB, Hoogstraten B and Staquet H: Reporting results of cancer treatment. Cancer 47: , Pannuti F, Lelli G, Rossi AP et al: Il protocollo terapeutico in clinica oncologica. In: Trattato di Clinica Oncologica. Pannuti F (ed.). Vol. I. Piccin, Padova, pp , Kaplan EL and Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: , Samelis GF, Skarlos D, Bafaloukos D et al: The combination of estramustine and mitoxantrone in hormone-refractory prostate cancer: a phase II feasibility study conducted by the Hellenic Cooperative Oncology Group. Urology 61: , Samelis GF, Kalofonos H, Adamou A et al: The combination of estramustine, vinorelbine, and mitoxantrone in hormone-refractory prostate cancer : a phase II study conducted by the Hellenic Cooperative Oncology Group. Urology 66: , Bernardi D, Talamini R, Zanetti M et al: Mitoxantrone, vinorelbine and prednisone (MVD) in the treatment of metastatic hormonoresistant prostate cancer a phase II trial. Prostate Cancer Prostatic Disease 7: 45-49, Tannock IF, de Wit R, Berry WB et al: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351: , Petrylak DP, Tangen CM, Hussain MH et al: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 351: , Received February 2, 2006 Accepted March 16,

Recent Progress in Management of Advanced Prostate Cancer

Recent Progress in Management of Advanced Prostate Cancer Review Article [1] April 15, 2005 By Philip W. Kantoff, MD [2] Androgen-deprivation therapy, usually with combined androgen blockade, is standard initial treatment for advanced prostate cancer. With failure

More information

New Hope for Patients with Metastatic Hormone-Refractory Prostate Cancer

New Hope for Patients with Metastatic Hormone-Refractory Prostate Cancer european urology supplements 5 (2006) 817 823 available at www.sciencedirect.com journal homepage: www.europeanurology.com New Hope for Patients with Metastatic Hormone-Refractory Prostate Cancer Ronald

More information

trial update clinical

trial update clinical trial update clinical by John W. Mucenski, BS, PharmD, Director of Pharmacy Operations, UPMC Cancer Centers The treatment outcome for patients with relapsed or refractory cervical carcinoma remains dismal.

More information

Phase II Clinical Trial of GM-CSF Treatment in Patients with Hormone-Refractory or Hormone-Naïve Adenocarcinoma of the Prostate

Phase II Clinical Trial of GM-CSF Treatment in Patients with Hormone-Refractory or Hormone-Naïve Adenocarcinoma of the Prostate ORIGINAL RESEARCH Phase II Clinical Trial of GM-CSF Treatment in Patients with Hormone-Refractory or Hormone-Naïve Adenocarcinoma of the Prostate Robert J. Amato and Joan Hernandez-McClain Genitourinary

More information

Docetaxel in Combination with Prednisolone for Hormone Refractory Prostate Cancer

Docetaxel in Combination with Prednisolone for Hormone Refractory Prostate Cancer Original Article Japanese Journal of Clinical Oncology Advance Access published October 22, 2009 Jpn J Clin Oncol 2009 doi:10.1093/jjco/hyp126 Docetaxel in Combination with Prednisolone for Hormone Refractory

More information

mcrpc 2014 TRA EVOLUZIONE E RIVOLUZIONE: COME ORIENTARSI NEL LABIRINTO DELLE TERAPIE

mcrpc 2014 TRA EVOLUZIONE E RIVOLUZIONE: COME ORIENTARSI NEL LABIRINTO DELLE TERAPIE mcrpc 2014 TRA EVOLUZIONE E RIVOLUZIONE: COME ORIENTARSI NEL LABIRINTO DELLE TERAPIE IL CARCINOMA PROSTATICO, UNA MALATTIA ETEROGENEA? RAZIONALE E RISULTATI DEL TRATTAMENTO CHEMIOTERAPICO ASSOCIATO ALL

More information

Weekly Administration of Docetaxel in Patients with Hormonerefractory Prostate Cancer: a Pilot Study on Japanese Patients

Weekly Administration of Docetaxel in Patients with Hormonerefractory Prostate Cancer: a Pilot Study on Japanese Patients Jpn J Clin Oncol 2004;34(3)137 141 Weekly Administration of Docetaxel in Patients with Hormonerefractory Prostate Cancer: a Pilot Study on Japanese Patients Takahiro Kojima, Toru Shimazui, Mizuki Onozawa,

More information

Gemcitabine and Carboplatin in Patients with Refractory or Progressive Metastatic Breast Cancer after Treatment

Gemcitabine and Carboplatin in Patients with Refractory or Progressive Metastatic Breast Cancer after Treatment DOI: 10.18056/seci2014.6 Gemcitabine and Carboplatin in Patients with Refractory or Progressive Metastatic Breast Cancer after Treatment Zedan A 1, Soliman M 2, Sedik MF 1 1 Medical Oncology Department,

More information

Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel

Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer second line after docetaxel April 2009 This technology summary is based on information available at the time of research and a

More information

LONDON CANCER NEW DRUGS GROUP RAPID REVIEW

LONDON CANCER NEW DRUGS GROUP RAPID REVIEW LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Abiraterone for the treatment of metastatic castration-resistant prostate cancer that has progressed on or after a docetaxel-based chemotherapy regimen Disease

More information

Session 4 Chemotherapy for castration refractory prostate cancer First and second- line chemotherapy

Session 4 Chemotherapy for castration refractory prostate cancer First and second- line chemotherapy Session 4 Chemotherapy for castration refractory prostate cancer First and second- line chemotherapy October- 2015 ESMO 2004 October- 2015 Fyraftensmøde 2 2010 October- 2015 Fyraftensmøde 3 SWOG 9916 OS

More information

This was a multicenter study conducted at 11 sites in the United States and 11 sites in Europe.

This was a multicenter study conducted at 11 sites in the United States and 11 sites in Europe. Protocol CAM211: A Phase II Study of Campath-1H (CAMPATH ) in Patients with B- Cell Chronic Lymphocytic Leukemia who have Received an Alkylating Agent and Failed Fludarabine Therapy These results are supplied

More information

Primary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.

Primary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause. CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase

More information

Efficacy of Taxotere, Thalidomide, and Prednisolone in Patients with Hormone- Resistant Metastatic Prostate Cancer

Efficacy of Taxotere, Thalidomide, and Prednisolone in Patients with Hormone- Resistant Metastatic Prostate Cancer Efficacy of Taxotere, Thalidomide, and Prednisolone in Patients with Hormone- Resistant Metastatic Prostate Cancer Hamid Rezvani, Shirin Haghighi, Mojtaba Ghadyani, Hamid Attarian UROLOGICAL ONCOLOGY Taleghani

More information

Lower Baseline PSA Predicts Greater Benefit From Sipuleucel-T

Lower Baseline PSA Predicts Greater Benefit From Sipuleucel-T Lower Baseline PSA Predicts Greater Benefit From Sipuleucel-T Schelhammer PF, Chodak G, Whitmore JB, Sims R, Frohlich MW, Kantoff PW. Lower baseline prostate-specific antigen is associated with a greater

More information

X, Y and Z of Prostate Cancer

X, Y and Z of Prostate Cancer X, Y and Z of Prostate Cancer Dr Tony Michele Medical Oncologist Prostate cancer Epidemiology Current EUA (et al) guidelines on Advanced Prostate Cancer Current clinical management in specific scenarios

More information

Advanced Prostate Cancer. November Jose W. Avitia, M.D

Advanced Prostate Cancer. November Jose W. Avitia, M.D Advanced Prostate Cancer November 4 2017 Jose W. Avitia, M.D In 2017 161,000 new cases of prostate cancer diagnosed in US, mostly with elevated PSA 5-10% will present with metastatic disease In 2017: 26,000

More information

SESSIONE PLATINUM SERIES (Best Papers Poster o Abstract on Prostate Cancer) In Oncologia

SESSIONE PLATINUM SERIES (Best Papers Poster o Abstract on Prostate Cancer) In Oncologia SESSIONE PLATINUM SERIES (Best Papers Poster o Abstract on Prostate Cancer) In Oncologia Divisione di Oncologia Medica Unità Tumori Genitourinari SESSIONE PLATINUM SERIES (Best Papers Poster o Abstract

More information

Plattenepithelkarzinom des Ösophagus, 1 st -line

Plattenepithelkarzinom des Ösophagus, 1 st -line Plattenepithelkarzinom des Ösophagus, 1 st -line AIO-STO-0309 An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced

More information

Outcomes of Dose-Attenuated Docetaxel in Asian Patients with Castrate-Resistant Prostate Cancer

Outcomes of Dose-Attenuated Docetaxel in Asian Patients with Castrate-Resistant Prostate Cancer Original Article 195 Outcomes of Dose-Attenuated Docetaxel in Asian Patients with Castrate-Resistant Prostate Cancer Jia Wei Ang, 1, Min-Han Tan, 1,2 MBBS, MRCP, PHD, Miah Hiang Tay, 3 MBBS, MRCP, Chee

More information

Belotecan and Cisplatin Combination Chemotherapy for Previously Untreated Extensive-Disease Small Cell Lung Cancer

Belotecan and Cisplatin Combination Chemotherapy for Previously Untreated Extensive-Disease Small Cell Lung Cancer J Lung Cancer 2010;9(1):15-19 Belotecan and Cisplatin Combination Chemotherapy for Previously Untreated Extensive-Disease Small Cell Lung Cancer Purpose: Belotecan (Camtobell R ; Chong Keun Dang Co., Seoul,

More information

Strontium 89 Combined with Gemcitabine in Androgen-Resistant Prostate Cancer: Results of a Phase I-II Study

Strontium 89 Combined with Gemcitabine in Androgen-Resistant Prostate Cancer: Results of a Phase I-II Study 54 The Open Prostate Cancer Journal, 2009, 2, 54-58 Open Access Strontium 89 Combined with Gemcitabine in Androgen-Resistant Prostate Cancer: Results of a Phase I-II Study Keizman Daniel, Maimon Natalie,

More information

symposium article introduction symposium article

symposium article introduction symposium article Annals of Oncology 17 (Supplement 5): v118 v122, 2006 doi:10.1093/annonc/mdj965 Long-term survival results of a randomized trial comparing gemcitabine/cisplatin and methotrexate/ vinblastine/doxorubicin/cisplatin

More information

www.drpaulmainwaring.com Figure 1 Androgen action Harris W P et al. (2009) Nat Clin Pract Urol doi:10.1038/ncpuro1296 Figure 2 Mechanisms of castration resistance in prostate cancer Harris W P et al. (2009)

More information

Sponsor / Company: Sanofi Drug substance(s): Docetaxel (Taxotere )

Sponsor / Company: Sanofi Drug substance(s): Docetaxel (Taxotere ) These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):

More information

Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer

Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer Original article Annals of Oncology 13: 1862 1867, 2002 DOI: 10.1093/annonc/mdf308 Phase I/II study of paclitaxel, gemcitabine and vinorelbine as first-line chemotherapy of non-small-cell lung cancer V.

More information

Study population The study population comprised patients with the following characteristics:

Study population The study population comprised patients with the following characteristics: Paclitaxel plus carboplatin, compared with paclitaxel plus gemcitabine, shows similar efficacy while more cost-effective: a randomized phase II study of combination chemotherapy against inoperable non-small-cell

More information

Supplementary Material

Supplementary Material 1 Supplementary Material 3 Tumour Biol. 4 5 6 VCP Gene Variation Predicts Outcome of Advanced Non-Small-Cell Lung Cancer Platinum-Based Chemotherapy 7 8 9 10 Running head: VCP variation predicts NSCLC

More information

When exogenous testosterone therapy is. adverse responses can be induced.

When exogenous testosterone therapy is. adverse responses can be induced. Theoretical tips It has been reasoned that discontinuation of ADT in nonorchiectomized patients may have detrimental effect on patients with CRPC as discontinuation of ADT can result in renewed release

More information

Definition Prostate cancer

Definition Prostate cancer Prostate cancer 61 Definition Prostate cancer is a malignant neoplasm that arises from the prostate gland and the most common form of cancer in men. localized prostate cancer is curable by surgery or radiation

More information

SYSTEMIC THERAPIES FOR CRPC: Chemotherapy and Radium-223

SYSTEMIC THERAPIES FOR CRPC: Chemotherapy and Radium-223 SYSTEMIC THERAPIES FOR CRPC: Chemotherapy and Radium-223 ELENA CASTRO Spanish National Cancer Research Centre Prostate Preceptorship. Lugano 4-5 October 2018 Disclosures Participation in advisory boards:

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

This was a multi-center study conducted at 44 study centers. There were 9 centers in the United States and 35 centers in Europe.

This was a multi-center study conducted at 44 study centers. There were 9 centers in the United States and 35 centers in Europe. Protocol CAM307: A Phase 3 Study to Evaluate the Efficacy and Safety of Frontline Therapy with Alemtuzumab (Campath ) vs Chlorambucil in Patients with Progressive B-Cell Chronic Lymphocytic Leukemia These

More information

Irinotecan (CPT-11) in Patients with Advanced Colon Carcinoma Relapsing after 5-Fluorouracil-Leucovorin Combination

Irinotecan (CPT-11) in Patients with Advanced Colon Carcinoma Relapsing after 5-Fluorouracil-Leucovorin Combination Clinical Report Chemotherapy 2002;48:94 99 Irinotecan (CPT-11) in Patients with Advanced Colon Carcinoma Relapsing after 5-Fluorouracil-Leucovorin Combination N.B. Tsavaris a A. Polyzos b K. Gennatas c

More information

ISPUB.COM. S Ravi-Kumar, S Lee, I Rabinowitz, C Verschraegen INTRODUCTION

ISPUB.COM. S Ravi-Kumar, S Lee, I Rabinowitz, C Verschraegen INTRODUCTION ISPUB.COM The Internet Journal of Oncology Volume 7 Number 2 Does Ethnicity Influence Response To Docetaxel Based- Chemotherapy For Patients With Castration Resistant Prostate Cancer? The New Mexico Perspective.

More information

Synopsis. Study Phase and Title: Study Objectives: Overall Study Design

Synopsis. Study Phase and Title: Study Objectives: Overall Study Design Synopsis Study Phase and Title: Study Objectives: Overall Study Design Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib

More information

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma

Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma Denosumab (AMG 162) for bone metastases from solid tumours and multiple myeloma September 2008 This technology summary is based on information available at the time of research and a limited literature

More information

Name of Policy: Cellular Immunotherapy for Prostate Cancer

Name of Policy: Cellular Immunotherapy for Prostate Cancer Name of Policy: Cellular Immunotherapy for Prostate Cancer Policy #: 432 Latest Review Date: July 2014 Category: Medical Policy Grade: A Background/Definitions: As a general rule, benefits are payable

More information

Common disease 175,000 new cases/year 44,000 deaths/year Less than 10% with newly diagnosed at presentation have stage IV disease Chronic disease,

Common disease 175,000 new cases/year 44,000 deaths/year Less than 10% with newly diagnosed at presentation have stage IV disease Chronic disease, Chemotherapy for Metastatic Breast Cancer: Recent Results HARMESH R. NAIK, MD. Karmanos Cancer Institute and St. Mary Hospital Metastatic breast cancer (MBC) Common disease 175,000 new cases/year 44,000

More information

Supplementary Appendix

Supplementary Appendix Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib

More information

The legally binding text is the original French version

The legally binding text is the original French version The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 29 November 2006 TAXOTERE 20 mg, concentrate and solvent for infusion in single-dose vials of 7 ml, individually packed

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Proposed Health Technology Appraisal Radium-223 chloride for the treatment of bone metastases in castrate resistant prostate cancer Draft scope Draft

More information

Please consider the following information on ZYTIGA (abiraterone acetate). ZYTIGA - Compendia Communication - NCCN LATITUDE and STAMPEDE June 2017

Please consider the following information on ZYTIGA (abiraterone acetate). ZYTIGA - Compendia Communication - NCCN LATITUDE and STAMPEDE June 2017 Page 1 of 2 Janssen Scientific Affairs, LLC 1125 Trenton-Harbourton Road PO Box 200 Titusville, NJ 08560 800.526.7736 tel 609.730.3138 fax June 08, 2017 Joan McClure 275 Commerce Drive #300 Fort Washington,

More information

National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Trial design:

National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Trial design: Open clinical uro-oncology trials in Canada Eric Winquist, MD, Mary J. Mackenzie, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada BLADDER CANCER A PHASE III STUDY OF IRESSA

More information

NCCP Chemotherapy Protocol

NCCP Chemotherapy Protocol Docetaxel Monotherapy 50mg/m 2 INDICATIONS FOR USE: INDICATION In combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer

More information

Prostate cancer is the most common non skin cancer in the United States.

Prostate cancer is the most common non skin cancer in the United States. OPTIMIZING TREATMENT FOR ADVANCED PROSTATE CANCER Docetaxel and Thalidomide as a Treatment Option for Androgen- Independent, Nonmetastatic Prostate Cancer Gregory D. Leonard, MD, William L. Dahut, MD,

More information

Policy. not covered Sipuleucel-T. Considerations Sipuleucel-T. Description Sipuleucel-T. be medically. Sipuleucel-T. covered Q2043.

Policy. not covered Sipuleucel-T. Considerations Sipuleucel-T. Description Sipuleucel-T. be medically. Sipuleucel-T. covered Q2043. Cellular Immunotherapy forr Prostate Cancer Policy Number: 8.01.53 Origination: 11/2010 Last Review: 11/2014 Next Review: 11/2015 Policy BCBSKC will provide coverage for cellular immunotherapy for prostate

More information

Evolution of Chemotherapy for. Cancer

Evolution of Chemotherapy for. Cancer Evolution of Chemotherapy for Hormone Refractory Prostate t Cancer Ian F Tannock MD, PhD Daniel E Bergsagel Professor of Medical Oncology Princess Margaret Hospital and University of Toronto In 1985, two

More information

January Abiraterone pre-docetaxel for patients with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer

January Abiraterone pre-docetaxel for patients with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Abiraterone pre-docetaxel for asymptomatic/minimally symptomatic metastatic castration resistant prostate cancer Abiraterone pre-docetaxel for patients with asymptomatic

More information

Higher Doses of Mitoxantrone among Men with Hormone-Refractory Prostate Carcinoma

Higher Doses of Mitoxantrone among Men with Hormone-Refractory Prostate Carcinoma 665 Higher Doses of Mitoxantrone among Men with Hormone-Refractory Prostate Carcinoma A Cancer and Leukemia Group B Study Ellis G. Levine, M.D. 1 Susan Halabi, Ph.D. 2 John D. Roberts, M.D. 3 Ellen B.

More information

Early Chemotherapy for Metastatic Prostate Cancer

Early Chemotherapy for Metastatic Prostate Cancer Early Chemotherapy for Metastatic Prostate Cancer Daniel P. Petrylak, MD Professor of Medicine and Urology Smilow Cancer Center Yale University Medical Center Disclosure Consultant: Sanofi Aventis, Celgene,

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Edith A. Perez, Ahmad Awada, Joyce O Shaughnessy, Hope Rugo, Chris Twelves, Seock-Ah Im, Carol Zhao, Ute Hoch, Alison L. Hannah, Javier Cortes

Edith A. Perez, Ahmad Awada, Joyce O Shaughnessy, Hope Rugo, Chris Twelves, Seock-Ah Im, Carol Zhao, Ute Hoch, Alison L. Hannah, Javier Cortes BEACON: A Phase 3 Open-label, Randomized, Multicenter Study of Etirinotecan Pegol (EP) versus Treatment of Physician s Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously

More information

Maximal androgen blockade versus castration alone in patients with metastatic prostate cancer*

Maximal androgen blockade versus castration alone in patients with metastatic prostate cancer* Chinese-German J Clin Oncol DOI 10.1007/s10330-014-0037-9 September 2014, Vol. 13, No. 9, P417 P421 Maximal androgen blockade versus castration alone in patients with metastatic prostate cancer* Abeer

More information

Low Dose Docetaxel Combined With Low Dose Capecitabine in Treatment of Metastatic Breast Cancer Previously Treated With Anthracycline

Low Dose Docetaxel Combined With Low Dose Capecitabine in Treatment of Metastatic Breast Cancer Previously Treated With Anthracycline Low Dose Docetaxel Combined With Low Dose Capecitabine in Treatment of Metastatic Breast Cancer Previously Treated With Anthracycline Rabab Mahmoud and Omnia Abd-elfattah Clinical Oncology Department,

More information

Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer

Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer The new england journal of medicine original article Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer Daniel P. Petrylak, M.D., Catherine M.

More information

PRO STATE of the art. METASTATIC HORMONE SENSITIVE PROSTATE CANCER Clinical case and evidences from literature

PRO STATE of the art. METASTATIC HORMONE SENSITIVE PROSTATE CANCER Clinical case and evidences from literature PRO STATE of the art METASTATIC HORMONE SENSITIVE PROSTATE CANCER Clinical case and evidences from literature Marcello Tucci, MD Department of Oncology San Luigi Gonzaga Hospital Orbassano, Turin 30 MAY

More information

Published on The YODA Project (

Published on The YODA Project ( Principal Investigator First Name: David Last Name: Lorente Degree: MD Primary Affiliation: Medical Oncology Service, Hospital Provincial de Castellón E-mail: lorente.davest@gmail.com Phone number: +34

More information

Docetaxel. Class: Antineoplastic agent, Antimicrotubular, Taxane derivative.

Docetaxel. Class: Antineoplastic agent, Antimicrotubular, Taxane derivative. Docetaxel Class: Antineoplastic agent, Antimicrotubular, Taxane derivative. Indications: -Breast cancer: -Non small cell lung cancer -Prostate cancer -Gastric adenocarcinoma _Head and neck cancer Unlabeled

More information

Prostate Case Scenario 1

Prostate Case Scenario 1 Prostate Case Scenario 1 H&P 5/12/16: A 57-year-old Hispanic male presents with frequency of micturition, urinary urgency, and hesitancy associated with a weak stream. Over the past several weeks, he has

More information

Weekly Paclitaxel for Metastatic Breast Cancer in Patients Previously Exposed to Paclitaxel

Weekly Paclitaxel for Metastatic Breast Cancer in Patients Previously Exposed to Paclitaxel www.journalofcancerology.com PERMANYER J Cancerol. 0;:-9 JOURNAL OF CANCEROLOGY CLINICAL CASE Weekly Paclitaxel for Metastatic Breast Cancer in Patients Previously Exposed to Paclitaxel Benjamín Dávalos-Félix,

More information

Principal Investigator: Robert J. Jones, MD, Beatson Cancer Center, 1053 Great Western Road, Glasgow; United Kingdom

Principal Investigator: Robert J. Jones, MD, Beatson Cancer Center, 1053 Great Western Road, Glasgow; United Kingdom SYNOPSIS Issue Date: 14 October 2010 Document No.: EDMS-ERI-13494974:2.0 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Protocol No.: COU-AA-BE Cougar Biotechnology, Inc.

More information

Management of Incurable Prostate Cancer in 2014

Management of Incurable Prostate Cancer in 2014 Management of Incurable Prostate Cancer in 2014 Julie N. Graff, MD, MCR Portland VA Medical Center Assistant Professor of Medicine Knight Cancer Institute, OHSU 2014: Cancer Estimates Stage at Diagnosis

More information

Intermittent docetaxel chemotherapy is feasible for castration-resistant prostate cancer

Intermittent docetaxel chemotherapy is feasible for castration-resistant prostate cancer MOLECULAR AND CLINICAL ONCOLOGY 3: 303-307, 2015 Intermittent docetaxel chemotherapy is feasible for castration-resistant prostate cancer HARUKI KUME, TAKETO KAWAI, MASAYOSHI NAGATA, TAKESHI AZUMA, HIDEYO

More information

Trabectedin in ASTS. Le Cesne A, et al. J Clin Oncol. 2018;36(suppl): Abstract

Trabectedin in ASTS. Le Cesne A, et al. J Clin Oncol. 2018;36(suppl): Abstract Results of a Prospective Randomized Phase III T-SAR Trial Comparing Trabectedin vs Best Supportive Care (BSC) in Patients With Pretreated Advanced Soft Tissue Sarcoma (ASTS) Abstract 11508 Le Cesne A,

More information

BC Cancer Protocol Summary for Adjuvant Therapy for Breast Cancer Using Weekly PACLitaxel and Trastuzumab (HERCEPTIN)

BC Cancer Protocol Summary for Adjuvant Therapy for Breast Cancer Using Weekly PACLitaxel and Trastuzumab (HERCEPTIN) BC Cancer Protocol Summary for Adjuvant Therapy for Breast Cancer Using Weekly PACLitaxel and Trastuzumab (HERCEPTIN) Protocol Code: Tumour Group: Contact Physician: UBRAJTTW Breast Dr. Angela Chan ELIGIBILITY:

More information

Product: Darbepoetin alfa Clinical Study Report: Date: 22 August 2007 Page 2 of 14145

Product: Darbepoetin alfa Clinical Study Report: Date: 22 August 2007 Page 2 of 14145 Date: 22 ugust 2007 Page 2 of 14145 2. SYNOPSIS Name of Sponsor: mgen Inc., Thousand Oaks, C, US Name of Finished Product: ranesp Name of ctive Ingredient: Darbepoetin alfa Title of Study: Randomized,

More information

Performance Status and the Number of the Metastatic Sites are Powerful Prognostic Factors in Patients with Carcinomas of Unknown Primary Site

Performance Status and the Number of the Metastatic Sites are Powerful Prognostic Factors in Patients with Carcinomas of Unknown Primary Site Performance Status and the Number of the Metastatic Sites are Powerful Prognostic Factors in Patients with Carcinomas of Unknown Primary Site * Mohamed El-Shebiney and Alaa Maria Clinical Oncology Department,

More information

Open clinical uro-oncology trials in Canada George Rodrigues, MD, Mary J. Mackenzie, MD, Eric Winquist, MD

Open clinical uro-oncology trials in Canada George Rodrigues, MD, Mary J. Mackenzie, MD, Eric Winquist, MD Open clinical uro-oncology trials in Canada George Rodrigues, MD, Mary J. Mackenzie, MD, Eric Winquist, MD London Health Sciences Centre, London, Ontario, Canada BLADDER CANCER A MULTICENTRE, RANDOMIZED

More information

A randomized study of docetaxel and dexamethasone with low- or high-dose estramustine for patients with advanced hormone-refractory prostate cancer

A randomized study of docetaxel and dexamethasone with low- or high-dose estramustine for patients with advanced hormone-refractory prostate cancer Original Article DOCETAXEL AND DEXAMETHASONE WITH ESTRAMUSTINE FOR HORMONE-REFRACTORY PROSTATE CANCER NELIUS et al. A randomized study of docetaxel and dexamethasone with low- or high-dose estramustine

More information

Supplementary Online Content

Supplementary Online Content Supplementary Online Content Powles T, O Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 openlabel

More information

J Clin Oncol 23: by American Society of Clinical Oncology INTRODUCTION

J Clin Oncol 23: by American Society of Clinical Oncology INTRODUCTION VOLUME 23 NUMBER 21 JULY 20 2005 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T Long-Term Survival Results of a Randomized Trial Comparing Gemcitabine Plus Cisplatin, With Methotrexate, Vinblastine,

More information

Eribulin for locally advanced or metastatic breast cancer third line; monotherapy

Eribulin for locally advanced or metastatic breast cancer third line; monotherapy Eribulin for locally advanced or metastatic breast cancer third line; monotherapy April 2009 This technology summary is based on information available at the time of research and a limited literature search.

More information

ECF chemotherapy for liver metastases due to castration-resistant prostate cancer

ECF chemotherapy for liver metastases due to castration-resistant prostate cancer Original research ECF chemotherapy for liver metastases due to castration-resistant prostate cancer Shruti Gupta, BHSc; * Kylea Potvin, MD; * D. Scott Ernst, MD; * Frances Whiston; Eric Winquist, MD, MSc,

More information

TRANSPARENCY COMMITTEE OPINION. 29 April 2009

TRANSPARENCY COMMITTEE OPINION. 29 April 2009 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 29 April 2009 NAVELBINE 20 mg, soft capsules B/1 (CIP: 365 948-4) NAVELBINE 30 mg, soft capsules B/1 (CIP: 365 949-0)

More information

Phase II study of Gemcitabine and Cisplatin Regimen in Advanced Non-Small Cell Lung Cancer (NSCLC).

Phase II study of Gemcitabine and Cisplatin Regimen in Advanced Non-Small Cell Lung Cancer (NSCLC). Phase II study of Gemcitabine and Cisplatin Regimen in Advanced Non-Small Cell Lung Cancer (NSCLC). Hoseinzadeh Mollayosefy M., 1,* Iravani M., 1 Ghavamzadeh A., 1 Toogheh Gh., 2 Alimoghaddam K. 1 1 Department

More information

Lipoplatin monotherapy for oncologists

Lipoplatin monotherapy for oncologists Lipoplatin monotherapy for oncologists Dr. George Stathopoulos demonstrated that Lipoplatin monotherapy against adenocarcinomas of the lung can have very high efficacy (38% partial response, 43% stable

More information

STUDY FINDINGS PRESENTED ON TAXOTERE REGIMENS IN HEAD AND NECK, LUNG AND BREAST CANCER

STUDY FINDINGS PRESENTED ON TAXOTERE REGIMENS IN HEAD AND NECK, LUNG AND BREAST CANCER Contact: Anne Bancillon + 33 (0)6 70 93 75 28 STUDY FINDINGS PRESENTED ON TAXOTERE REGIMENS IN HEAD AND NECK, LUNG AND BREAST CANCER Key results of 42 nd annual meeting of the American Society of Clinical

More information

OUR EXPERIENCES WITH ERLOTINIB IN SECOND AND THIRD LINE TREATMENT PATIENTS WITH ADVANCED STAGE IIIB/ IV NON-SMALL CELL LUNG CANCER

OUR EXPERIENCES WITH ERLOTINIB IN SECOND AND THIRD LINE TREATMENT PATIENTS WITH ADVANCED STAGE IIIB/ IV NON-SMALL CELL LUNG CANCER & OUR EXPERIENCES WITH ERLOTINIB IN SECOND AND THIRD LINE TREATMENT PATIENTS WITH ADVANCED STAGE IIIB/ IV NON-SMALL CELL LUNG CANCER Interim Data Report of TRUST study on patients from Bosnia and Herzegovina

More information

Sequential Adriamycin and CMF in Metastatic Breast Cancer

Sequential Adriamycin and CMF in Metastatic Breast Cancer Sequential Adriamycin and CMF in Metastatic Breast Cancer M. ZAMBETTI, A. GIACOBONE, M. TERENZIANI, P. ZUCCHINELLI, R. DEMICHELI, S. BIASI, P. PIOTTI, C. BARTOLI, P. VALAGUSSA, G. BONADONNA Istituto Nazionale

More information

OUR EXPERIENCE WITH ZOLEDRONIC ACID IN THE TREATMENT OF PATIENTS WITH NON- SMALL CELL LUNG CANCER AND BONE METASTASES

OUR EXPERIENCE WITH ZOLEDRONIC ACID IN THE TREATMENT OF PATIENTS WITH NON- SMALL CELL LUNG CANCER AND BONE METASTASES ISSN: 1312-773X (Online) DOI: 10.5272/jimab.2013191.391 Journal of IMAB - Annual Proceeding (Scientific Papers) 2013, vol. 19, issue 1 OUR EXPERIENCE WITH ZOLEDRONIC ACID IN THE TREATMENT OF PATIENTS WITH

More information

When exogenous testosterone therapy is. adverse responses can be induced.

When exogenous testosterone therapy is. adverse responses can be induced. Theoretical tips It has been reasoned that discontinuation of ADT in non orchiectomized patients may have detrimental effect on patients with CRPC as discontinuation of ADT can result in renewed release

More information

Combining Lurbinectedin and Doxorubicin The UCLH Experience in Small Cell Lung Cancer

Combining Lurbinectedin and Doxorubicin The UCLH Experience in Small Cell Lung Cancer Combining Lurbinectedin and Doxorubicin The UCLH Experience in Small Cell Lung Cancer Dr Martin Forster MD PhD Clinical Senior Lecturer in Experimental Cancer Medicine Consultant in Medical Oncology UCL

More information

MOLECULAR AND CLINICAL ONCOLOGY 4: , 2016

MOLECULAR AND CLINICAL ONCOLOGY 4: , 2016 MOLECULAR AND CLINICAL ONCOLOGY 4: 839-844, 2016 Clinical outcomes of anti androgen withdrawal and subsequent alternative anti-androgen therapy for advanced prostate cancer following failure of initial

More information

Chemotherapy for Urological Cancers

Chemotherapy for Urological Cancers Chemotherapy for Urologic Cancers Matthew Rettig, MD Associate Professor Department of Medicine Division of Hematology-Oncology Department of Urology Medical Director, Prostate Cancer Program Institute

More information

Sponsor / Company: Sanofi Drug substance(s): SAR (iniparib)

Sponsor / Company: Sanofi Drug substance(s): SAR (iniparib) These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):

More information

GASTRIC & PANCREATIC CANCER

GASTRIC & PANCREATIC CANCER GASTRIC & PANCREATIC CANCER ASCO HIGHLIGHTS 2005 Fadi Sami Farhat, MD Head of Hematology Oncology Division Hammoud Hospital University Medical Center Saida Lebanon Tel: +961 3 753 155 E-Mail: drfadi@drfadi.org

More information

VALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE

VALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE Session 3 Advanced prostate cancer VALUE AND ROLE OF PSA AS A TUMOUR MARKER OF RESPONSE/RELAPSE 1 PSA is a serine protease and the physiological role is believed to be liquefying the seminal fluid PSA

More information

PankoMab-GEX Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer

PankoMab-GEX Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer 1 von 7 13.01.2014 12:26 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: GEXMab25201 Previous Study Return to List Next Study PankoMab-GEX Versus Placebo as Maintenance Therapy

More information

New Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer

New Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer New Evidence reports on presentations given at ASCO 2012 New Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer Presentations at ASCO 2012 Breast

More information

Strategies for the Treatment of Elderly DLBCL Patients, New Combination Therapy in NHL, and Maintenance Rituximab Therapy in FL

Strategies for the Treatment of Elderly DLBCL Patients, New Combination Therapy in NHL, and Maintenance Rituximab Therapy in FL New Evidence reports on presentations given at ASH 2009 Strategies for the Treatment of Elderly DLBCL Patients, New Combination Therapy in NHL, and Maintenance Rituximab Therapy in FL From ASH 2009: Non-Hodgkin

More information

Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3

Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3 ESMO 2016 Congress 7-11 October, 2016 Copenhagen, Denmark Table of Contents Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3 Custirsen provides no additional survival benefit to cabazitaxel/prednisone

More information

Cancer de la prostate métastatique: prise en charge précoce

Cancer de la prostate métastatique: prise en charge précoce Cancer de la prostate métastatique: prise en charge précoce Stéphane Oudard, MD, PhD Georges Pompidou Hospital, Oncology Department, Paris, France stephane.oudard@egp.aphp.fr SAGB.CAB.14.08.0382c 3/02/2016

More information

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada BLADDER CANCER A MULTICENTRE, RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND

More information

Prostate cancer Management of metastatic castration sensitive cancer

Prostate cancer Management of metastatic castration sensitive cancer 18 th Annual Advances in Oncology - 2017 Prostate cancer Management of metastatic castration sensitive cancer Urothelial carcinoma Non-muscle invasive urothelial carcinoma Updates in metastatic urothelial

More information

Prostate Cancer 2009 MDV Anti-Angiogenesis. Anti-androgen Radiotherapy Surgery Androgen Deprivation Therapy. Docetaxel/Epothilone

Prostate Cancer 2009 MDV Anti-Angiogenesis. Anti-androgen Radiotherapy Surgery Androgen Deprivation Therapy. Docetaxel/Epothilone Prostate Cancer 2009 Anti-Angiogenesis MDV 3100 Anti-androgen Radiotherapy Surgery Androgen Deprivation Therapy Docetaxel/Epothilone Abiraterone DC therapy Bisphosphonates Denosumab Secondary Hormonal

More information

Medical Treatments for Prostate Cancer

Medical Treatments for Prostate Cancer Medical Treatments for Prostate Cancer Ian F Tannock MD, PhD Daniel E Bergsagel Professor of Medical Oncology, Princess Margaret Hospital and University of Toronto March 17, 2005 Brampton 1 A hypothetical

More information

reviews LHRH Agonists in the Treatment of Advanced Carcinoma of the Prostate therapy

reviews LHRH Agonists in the Treatment of Advanced Carcinoma of the Prostate therapy reviews therapy LHRH Agonists in the Treatment of Advanced Carcinoma of the Prostate Martin I. Resnick, MD, Lester Persky Professor and Chief, Department of Urology, Case Western Reserve University School

More information

Three-week versus four-week schedule of cisplatin and gemcitabine: results of a randomized phase II study

Three-week versus four-week schedule of cisplatin and gemcitabine: results of a randomized phase II study Original article Annals of Oncology 13: 1080 1086, 2002 DOI: 10.1093/annonc/mdf186 Three-week versus four-week schedule of cisplatin and gemcitabine: results of a randomized phase II study H. Soto Parra

More information

Initial Hormone Therapy

Initial Hormone Therapy Initial Hormone Therapy Alan Horwich Institute of Cancer Research and Royal Marsden Hospital, London, UK Alan.Horwich@icr.ac.uk MANAGEMENT OF PROSTATE CANCER Treatment windows Subclinical Localised PSA

More information